US11642356B2ActiveUtilityA1

Pharmaceutical compositions

45
Assignee: HULL WADEPriority: Oct 21, 2016Filed: Oct 21, 2016Granted: May 9, 2023
Est. expiryOct 21, 2036(~10.3 yrs left)· nominal 20-yr term from priority
A61K 9/0014A61K 9/08A61P 17/06A61K 31/573A61K 47/12A61K 47/14
45
PatentIndex Score
0
Cited by
8
References
11
Claims

Abstract

In one example presented herein, is a pharmaceutical composition. The pharmaceutical composition can include halobetasol propionate, from 0 wt % to 3 wt % ethoxylated castor oil, a first compound, and a second compound. The first compound and the second compound can be selected from; N-lauroyl sarcosine, sodium octyl sulfate, methyl laurate, isopropyl myristate, oleic acid, glyceryl oleate, and sodium lauryl sulfoacetate. The first compound and the second compound are not the same.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
       1. A pharmaceutical composition comprising:
 0.01-10 wt % halobetasol propionate; 
 1-45 wt % isopropyl alcohol; 
 1-10 wt % di-isopropyl adipate; 
 1-15 wt % hexylene glycol; 
 30-60 wt % water; 
 0.01-5 wt % methyl laurate; 
 0.01-5 wt % oleic acid; 
 0.01-2 wt % citric acid; and 
 0.01-2 wt % sodium citrate (dihydrate), 
 wherein the composition is devoid of ethoxylated castor oil. 
 
     
     
       2. The pharmaceutical composition of  claim 1 , formulated as a topical spray. 
     
     
       3. The pharmaceutical composition of  claim 1 , wherein no degradation product is observed at a relative retention time of 0.76-0.77 for the halobetasol propionate following 3 months of storage at long term conditions of 25° C.±2° C. and 60%±5% relative humidity. 
     
     
       4. The pharmaceutical composition of  claim 1 , wherein no degradation product is observed at a relative retention time of 0.76-0.77 for the halobetasol propionate following 6 months of storage at long term conditions of 25° C.±2° C. and 60%±5% relative humidity. 
     
     
       5. The pharmaceutical composition of  claim 1 , wherein no degradation product is observed at a relative retention time of 0.76-0.77 for the halobetasol propionate following 9 months of storage at long term conditions of 25° C.±2° C. and 60%±5% relative humidity. 
     
     
       6. The pharmaceutical composition of  claim 1 , wherein a mean score resulting from vasoconstriction testing is at least 2. 
     
     
       7. The pharmaceutical composition of  claim 1 , wherein a weight ratio of methyl laurate to oleic acid ranges from about 1:2 to about 15:1. 
     
     
       8. The pharmaceutical composition of  claim 1 , wherein a weight ratio of the methyl laurate to the oleic acid ranges from about 1:2 to about 2:1. 
     
     
       9. The pharmaceutical composition of  claim 8 , wherein the weight ratio is about 1:1. 
     
     
       10. The pharmaceutical composition of  claim 1 , wherein the halobetasol propionate ranges from about 0.25 wt % to about 2 wt %. 
     
     
       11. The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition is devoid of sodium lauryl sulfoacetate.

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